Class I Medical Devices – Conformity Assessment Routes (EU MDR)

Updated on November 17, 2020

According to the Medical Devices Regulations of the European Union (EU MDR), medical devices are classified as class I devices if they pose the least risk to the user. The conformity assessment routes for these devices to enable their marketing in the European Union countries is simpler than for devices belonging to higher classes.

Except for custom-made and investigational devices, class I devices must draw up the technical documentation set out in Annexes II and III, followed by a declaration of conformity according to Annex IV. The CE marking is granted according to Annex V. The notified body does not get involved in the conformity assessment of these devices.

The technical documentation listed under Annex II for class I devices should include the following:

Device information including a description of its accessories, variants and raw materials. An overview of previous and similar generations of the device, if they exist, should also be documented
The label/s on the device and the instructions for use in a language accepted in the country where it is intended to be sold
Information about the design stages and manufacturing processes, including identification of sites where these activities are performed
General safety and performance requirements
Benefit-risk analysis and risk management. The manufacturer must document a risk management plan for the device, identify and analyze the known and foreseeable hazards, including when the device is misused, and adopt risk-control measures to eliminate such risks.
Product verification and validation, from pre-clinical and clinical studies. The details of the design of the tests should also be documented. The documentation should include the clinical evaluation plan and report, and where applicable, the post-market clinical follow-up plan or evaluation report.

The technical documentation under Annex III is related to the post-market surveillance. It includes the post-market surveillance plan and the post-market surveillance report for the device.

The technical documentation is followed by the declaration of conformity as detailed in Annex IV. It includes the statements that the declaration is issued under the sole responsibility of the manufacturer and that the device is in conformity with the regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity.

Once approved, the device is certified and gets its CE marking.

For class I devices that are sterile (Is), have a measuring function (Im) or are reusable surgical instruments (Ir), the conformity route is slightly different. The manufacturer can follow either Chapters I and III of Annex IX, or Part A of Annex XI. This is followed by a declaration of conformity according to Annex IV. The CE marking is granted according to Annex V. For these devices, the notified body is involved in verifying the establishment, securing and maintenance of sterile conditions of the Is devices, the metrological requirements of the Im devices, and aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions of the Ir devices.

According to chapter I of Annex IX, the application to the notified body should include:

The details of the manufacturer as well as the device
Details of the manufacturer’s quality management system
Post-market surveillance system
Where applicable, the post-market clinical follow-up plan and the clinical evaluation plan.
A description of the organization of the business
Documentation related to the monitoring, verifying, validating and controlling the design of the devices, the verification and quality assurance techniques at the manufacturing stage
The details of the appropriate tests and trials which are to be carried out before, during and after manufacture.

In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III.

According to Chapter III of Annex IX, the manufacturer or the authorised representative must keep the device-related documents at the disposal of the competent authorities for a minimum period of 10 years after the last device was placed in the market. Beside the above documents, these include:

The EU declaration of conformity
Information about substantial changes to the quality management system, or the device-range covered
The decisions and reports from the notified body

If the manufacturer follows Part A of Annex XI, the application with a notified body will include:

Details of the manufacturer and the device
A written declaration that no application has been lodged with any other notified body for the same device- related quality management system, or information about any previous application for the same device- related quality management system
A draft of an EU declaration of conformity
Details of the manufacturer’s quality management system
The post-market surveillance system
Where applicable, the post-market clinical follow-up plan, the clinical evaluation plan, and the technical documentation referred to in Annexes II and III for the types approved.

In addition, for sterile devices, a description of the methods used and the validation reports regarding the packaging, sterilisation and maintenance of sterility of the device should be provided. The validation report must address the bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. For devices with a measuring function, a description of the methods used to ensure the accuracy as given in the specifications should be provided.

Other documents that must be provided are a copy of the EU type-examination certificates, the manufacturer’s quality objectives and quality assurance techniques, the organisation of the business. The manufacturer must inform the notified body of any plan for substantial changes to the quality management system, or the device-range covered.

This is followed by the declaration of conformity as detailed in Annex IV. It includes statements that the declaration is issued under the sole responsibility of the manufacturer and that the device is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity.

Once approved, the device is certified and gets its CE marking.

This article is for informational purposes only and not intended to replace the relationship between the doctor and the patient. It should not be used for self-treatment by patients or by doctors to treat patients. Consult your doctor before using any of the above information.

Back to Medical Devices

Reference:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN